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Medivir's Fostrox Receives FDA Clearance for Phase IIb Liver Cancer Trial

• Medivir has received FDA approval for its Investigational New Drug (IND) application to proceed with a Phase IIb trial of fostrox in combination with Lenvima. • The Phase IIb trial will evaluate the efficacy of fostrox combined with Lenvima as a second-line treatment for advanced liver cancer compared to Lenvima alone. • This trial builds upon promising Phase Ib/IIa results, with the aim of establishing the combination as the first approved second-line treatment for liver cancer. • Medivir's CEO, Jens Lindberg, views the IND approval as a significant milestone for the company and the development of fostrox.

Medivir has announced FDA clearance to proceed with a Phase IIb clinical trial evaluating fostrox in combination with Lenvima (lenvatinib) for the second-line treatment of advanced hepatocellular carcinoma (HCC), the most common type of liver cancer. The study will assess the combination therapy's effectiveness against Lenvima monotherapy, building on encouraging results from a previous Phase Ib/IIa trial. The goal is to establish fostrox plus Lenvima as the first approved treatment option for patients with liver cancer who have progressed on first-line therapies.
The Phase IIb trial is designed to evaluate the clinical benefit of adding fostrox to the standard-of-care Lenvima in patients with advanced HCC who have failed or are intolerant to prior systemic therapy. The primary endpoint is expected to be overall survival (OS), with secondary endpoints including progression-free survival (PFS), objective response rate (ORR), and safety. Specific details regarding dosing regimens, administration routes, and patient inclusion criteria will be disclosed as the trial protocol is finalized.
"The IND approval is a very important milestone," stated Jens Lindberg, CEO of Medivir, in an interview with BioStock. This sentiment underscores the significance of the trial for Medivir and the potential impact on the treatment landscape for advanced liver cancer. The trial represents a crucial step in the development of fostrox and its potential to address the unmet need for effective second-line therapies in HCC.
Liver cancer is a significant global health burden, with HCC accounting for the majority of cases. While first-line treatments such as sorafenib and lenvatinib have improved outcomes, many patients experience disease progression, highlighting the need for effective second-line options. The current treatment landscape for second-line HCC is limited, and the development of new therapies is crucial to improve patient survival and quality of life. Medivir hopes that fostrox, in combination with lenvatinib, can fill this therapeutic gap.
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Reference News

[1]
Medivir's CEO to BioStock: “The IND approval is a very important milestone” - Cision News
news.cision.com · Dec 16, 2024

Medivir secures FDA approval for phase IIb trial of fostrox + Lenvima for advanced liver cancer, aiming to become the fi...

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